FDA.reportPublic FDA data

SAPROPTERIN DIHYDROCHLORIDE

Product NDC
49884-873
11-digit product format
498840873
Labeler code
49884
Product ID
49884-873_d9caf600-36bf-443b-bd05-cfeef3d84522
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SAPROPTERIN DIHYDROCHLORIDE
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Par Health USA, LLC
Application
ANDA210027
Marketing category
ANDA
Marketing start
2020-10-01
Substance
SAPROPTERIN DIHYDROCHLORIDE
Active strength
500 mg/1
Pharmacologic classes
Breast Cancer Resistance Protein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Phenylalanine Hydroxylase Activator [EPC], Phenylalanine Hydroxylase Activators [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SAPROPTERIN DIHYDROCHLORIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SAPROPTERIN DIHYDROCHLORIDE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRG277LF5B3
Rxcui1653217

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8c453acf-b173-4ab3-9044-65304cdd78bfProduct name520260211
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49884-873-52SAPROPTERIN DIHYDROCHLORIDE1 in 1 PACKETPOWDER, FOR SOLUTION124
49884-873-72SAPROPTERIN DIHYDROCHLORIDE30 in 1 CARTONPOWDER, FOR SOLUTION3024

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49884-873SAPROPTERIN DIHYDROCHLORIDE POWDER, FOR SOLUTION [ENDO USA, INC.]23Current NDC, Legacy NDC, 2 package rows20240713_2e13a3b5-e4df-4d5c-9b26-02a7006a7c3e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1653217sapropterin dihydrochloride 500 MG Powder for Oral SolutionPSN2e13a3b5-e4df-4d5c-9b26-02a7006a7c3e24
1653217sapropterin dihydrochloride 500 MG Powder for Oral SolutionSCD2e13a3b5-e4df-4d5c-9b26-02a7006a7c3e24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49884-873-52498840873521 in 1 PACKETHistorical
49884-873-724988408737230 PACKET in 1 CARTON (49884-873-72) / 1 POWDER, FOR SOLUTION in 1 PACKET (49884-873-52) 30 packet2020-10-010000-00-00NoNoCurrent